Performance and utility of a quick immunological method for the measurement of HbAlc in a pediatric diabetes unit.

This study compares the results of a new immunoassay method (DCA2000, Ames) used to measure HbAlc concentration in 9 min using 1-microliter capillary blood sample with those obtained with an ion exchange traditional method (HPLC, DIAMAT, Biorad) in both a non-diabetic and a diabetic pediatric population. All HbAlc values were measured in the two methods on the same whole-blood venous aliquot after we had excluded differences in HbAlc values measured by DCA2000 on venous and capillary blood samples (8.5 +/- 1.4 vs 8.6 +/- 1.4%). Data analysis shows an excellent correspondence between the two assays (r = 0.97; p < 0.0001). HbAlc values obtained by DCA2000 method in diabetic patients are related to the mean value of the blood glucose levels collected at home in the last two months (r = 0.74; p < 0.003). The percentile distribution of the HbAlc values is similar both in DCA2000 (3-- = 4.4; 50-- = 5.3; 97-- = 6.0%) and in HPLC method (3-- = 4; 50-- = 5; 97-- = 5.9%). Within-run precision for DCA2000 ranges from 3.7 to 1.9% and between-run precision from 4.5 to 0.9%. The new immunoassay method gives accurate and reliable HbA1c values and compared with HPLC methodology has at least three advantages: it does not require venipuncture, provides HbA1c value within 9 miy and allows both physician and patient to verify in virtually' real time the degree of blood glucose control.